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1084057

Abbvie Biotechnology Ltd. — FEI 3004620772

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 25, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Barceloneta, PR (United States)

Facility

Other inspections at this facility

  • 1222107 (VAI Mon Oct 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1055102 (VAI Fri Jun 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012249 (VAI Fri Apr 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 969277 (VAI Thu Mar 24 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 887947 (VAI Wed Jul 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
438221 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up